Research Compliance Definitions
- .118 Determination
- Adverse Event
- Animal Resource Unit
- Application for Vertebrate Animal Use (AVAU)
- Clinical Trial
- Commerce Control List (CCL)
- Conflict of Interest (COI)
- Conflicts of Commitment (COC)
- Contextualized Controlled Research Data
- Controlled Research
- Controlled Unclassified Information (CUI)
- Cooperative Research
- Countries/regions subject to U.S. Comprehensive Sanctions
- Covered Defense Information (CDI)
- Deemed Export
- Defense Article
- Effective Control
- End User
- Exemption Determination
- Expedited Approval
- Experimentally Naive
- Export Control Regulations
- External Professional Activity for Pay (EPAP)
- Foreign Person
- Full Board Approval
- Fundamental Research
- Human Subject
- Institutional Animal Care and Use Committee (IACUC)
- IACUC Protocol
- Identifiable Biospecimen
- Identifiable Private Information
- Institutional Review Board (IRB)
- International Traffic in Arms Regulations (ITAR)
- IRB Amendment
- IRB Approval
- IRB Approval Renewal (aka Continuing Review)
- Material Transfer Agreement (MTA)
- Minimal Risk
- Non-Contextualized Controlled Research Data
- Not Human Subject Research
- Notice of Intent
- Personally Identifiable Information (PII)
- PHS-Like Agencies
- Private Information
- Public Domain
- Reliance Agreement
- Research Misconduct
- Senior Personnel (NSF)
- Senior/Key Personnel (NIH)
- Significant Financial Interest (SFI)
- Technical Data
- Technology Control Plan (TCP)
- U.S. Government Restricted Party List
- U.S. Person
- Unanticipated Problem
- USDA Covered Animals
.118 Determination is a letter provided by the IRB that states that a study will involve research with human subjects but the protocol cannot be fully developed yet and it lacks immediate plans for the involvement of human subjects. This letter is often provided to a funder at the proposal stage or right before award.
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research (OHRP Guidance for Adverse Events)
Animal Resource Unit
An animal resource unit is an administrative unit that, for the purposes of this policy, acknowledges and accepts responsibility for tracking IACUC approval and approved animal numbers. That unit could be an animal facility (e.g., Biological Resources Facility); a collegewide service unit (e.g., CVM Laboratory Animal Resources); a University Field Lab or Field Station; or an academic department.
Application for Vertebrate Animal Use (AVAU)
Form that allows the investigator to communicate to the Institutional Animal Care and Use Committee (IACUC) their reasons for and methods of animal use. Once approved, this form is often referred to as an IACUC protocol.
Research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes (45 CFR 46.102b).
Commerce Control List (CCL)
The List of controlled items subject to the Export Administration Regulations (EAR). Technology or other controlled items subject to the EAR but not specifically enumerated on the CCL are considered EAR99 and are restricted, in most cases from Export to Countries/regions subject to U.S. Comprehensive Sanctions.
Conflict of Interest (COI)
Conflict of interest relates to situations in which financial or other personal considerations may compromise, may involve the potential for compromising, or may have the appearance of compromising an employee’s objectivity in meeting University duties or responsibilities. (REG 10.25.01 Section 4.2)
Conflicts of Commitment (COC)
Conflict of commitment relates to an individual’s distribution of effort between obligations to his or her University employment and participation in activities outside of University employment. The latter may include such generally encouraged extensions of professional expertise as professional consulting. A conflict of commitment occurs when the pursuit of such outside activities involves an investment of time that interferes with the employee’s duties and responsibilities. (REG 10.25.01 Section 4.1)
Contextualized Controlled Research Data
Information generated, processed, stored, and transmitted by a controlled research project subject to export control regulation. The information has been correlated with additional input form a person, application or second data source in scope of the controlled research project. Such data is fully subject to the federal regulations and contractual obligations and effective security controls must be maintained over such data as defined by the applicable Technology Control Plan.
Research either subject to publication restrictions or dissemination controls or which involves proprietary or controlled inputs that make it subject to export control regulations. Controlled Research is often protected with a Technology Control Plan.
Controlled Unclassified Information (CUI)
Controlled Unclassified information was defined in the Executive Order 13556 as information held by or generated for the federal government that requires safeguarding or dissemination controls pursuant to and consistent with applicable law, regulations and government-wide policies that isn’t classified under Executive Order 13526 or the Atomic Energy Act, as amended. Federal CUI is divided into several categories and subcategories and is listed in the CUI registry, managed by National Archives and Records Administration (NARA). CUI, by definition is federal information. (from Executive Order 13556) For more about NC State’s CUI program visit the CUI Program page https://research.ncsu.edu/administration/compliance/research-compliance/export-controls/cui/
Projects covered by the IRB regulations (45 CFR 46.114) that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.
Countries/regions subject to U.S. Comprehensive Sanctions
These countries/regions and their governments are sanctioned by the U.S. government. Most activities with or for entities or persons within these countries are subject to a license or authorization requirement. The list of comprehensively sanctioned countries is currently (subject to change): Cuba, Iran, North Korea, Syria and the Crimean, Donetsk and Luhansk regions of Ukraine. Note there are other countries subject to list-based sanctioned, which impact certain entities or persons within those countries. In most cases, these countries are also considered by the US Government to be state sponsors of terrorism.
Covered Defense Information (CDI)
Is a term defined in the DFAR clause 252.204-7012 Safeguarding Covered Defense Information as unclassified controlled technical information or other information, as described in the Controlled Unclassified Information (CUI) registry that requires safeguarding or dissemination controls pursuant to and consistent with law, regulations and government wide policies and is (1) Marked or otherwise identified in a contract, task order or delivery order and provided to Purdue by or on behalf of the DoD in support of the performance of a contract or (2) collected, developed, received, transmitted, used or stored by or on behalf of the contractor in support of the performance of the contract.
Releasing or otherwise transferring Technology (EAR) technical data (ITAR) or source code to a foreign person in the United States.
Any item or technical data designated on the U.S. Munitions List (USML) (22 CFR § 121.1). All items on the USML are subject to the ITAR.
Export Administration Regulations (15 CFR § 730 – 774) are the set of regulations administered by the U.S. Department of Commerce, Bureau of Industry and Security (BIS). The EAR regulates dual use items (items which have both civil and military applications) and related technology. Items subject to the EAR are categorized in the Commerce Control List (CCL) (15 CFR § 774). The EAR contains a number of defined terms (See 15 CFR §772.1)
ECCNs are five character alpha-numeric designations used on the Commerce Control List (CCL) to identify dual-use items for export control purposes. An ECCN categorizes items based on the nature of the product, i.e. type of commodity, software, or technology and its respective technical parameters.
The condition of certain temporary exports and reexports, you maintain effective control over an item when you either retain physical possession of the item, or secure the item in such an environment as a hotel safe, a bonded warehouse, or a locked or guarded exhibition facility. (15 CFR §772.1)
The person abroad that receives and ultimately uses the exported or reexported items. The end-user is not a forwarding agent or intermediary, but may be the purchaser or ultimate consignee.
Exemption Determination means that a study involving research with human subjects is determined to be minimal risk and it fits into the categories of exemption outlined in 45 CFR 46.104. Research studies determined Exempt from the regulations are considered research with human subjects. An Exemption determination means that not all of the regulations in 45 CFR 46 must be applied to the individual study and the NC State IRB office may instead choose to apply or not apply some standards. Studies reviewed at this level may be required to undergo a limited IRB review. Limited IRB review considers data protection and, where appropriate, broad consent.
Expedited Approval means that a study involving research with human subjects is both minimal risk and fit into one of the “Expedited Review Categories.” Every Expedited level study is subject to the regulations outlined in 45 CFR 46.110. Studies reviewed at the Expedited level must have all informed consent requirements at 45 CFR 46.116 (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111.
the IACUC defines experimentally naïve as a USDA Category B procedures, non-invasive procedures as USDA Category C procedures, and invasive procedures as USDA Category D or E procedures. Link to Classification of Animal Use by Pain and Distress Categories – https://research.ncsu.edu/administration/compliance/research-compliance/iacuc/iacuc-procedures-and-guidance/classification-of-animal-use-by-pain-and-distress-categories/
Includes the actual shipment or transmission out of the United States, even temporarily; releasing or otherwise transferring controlled technical data to a foreign person in the United States (“deemed export”)(See 15 CFR § 734.13 and 22 CFR § 120.17 for exact definitions)
Export Control Regulations
Federal regulations that control the export of information and physical items from the U.S. or to a Foreign Person within the United States. Regulations most commonly affecting university activity are the Export Administration Regulations (EAR), the International Traffic In Arms Regulations (ITAR) and the Sanction and Embargo programs overseen by the U.S. Treasury Department’s Office of Foreign Asset Controls (OFAC). There are other federal agencies and regulations that govern the export of specific items like nuclear material and medicine.
External Professional Activity for Pay (EPAP)
means any activity that 1) is not included within one’s University employment responsibilities; 2) is performed for any entity, public or private, other than the University employer; 3) is undertaken for compensation, including an equity interest in an external entity; and 4) is based upon the professional knowledge, experience and abilities of the EHRA employee for which that employee is employed by the University. Activities for pay not involving such professional knowledge, experience and abilities are not subject to the advance disclosure and approval requirements of this Policy, although they are subject to the basic requirement that outside activities of any type not result in neglect of primary University duties, conflicts of commitment or interest, inappropriate uses of the University name or resources, or claims of University responsibility for the activity. (REG 10.25.01 section 4.3)
Making up data or results and recording or reporting them. (REG 10.00.02 section 2.3)
Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. (REG 10.00.02 section 2.4)
Financial Conflict of Interest (FCOI)
Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.
Any person who is not a U.S. Citizen or lawful permanent resident (Green Card holder), and entities that are not incorporated or organized to do business in the United States. This includes students, visiting scholars and employees on non-immigrant visas as well as foreign subsidiaries of foreign parent companies of U.S. entities.
Full Board Approval
Full Board Approval means that a study involving research with human subjects is reviewed and approved by the convened Full IRB Board. These studies are considered either “more than minimal risk” to participants or they are “minimal risk” to participants but do not fit into any of the Expedited Categories. Studies reviewed at the Full Board level must have all informed consent requirements at 45 CFR 46.116 (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111.
Fundamental research means research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community, and for which the researchers have not accepted restrictions for proprietary or national security reasons. (15 CFR § 734.8(c)) (EAR Definition)
A living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens (45 CFR 46.102(e)(1)).
Institutional Animal Care and Use Committee (IACUC)
The committee, appointed by the chancellor, that has general concern and oversight for the welfare of animals used in research, teaching and testing.
See “Application for Vertibrate Animal Use (AVAU)“
A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.(45 CFR 46.102b(e)(1)(i)(6))
Identifiable Private Information
Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. (45 CFR 46.102b(e)(1)(i)(5))
Institutional Review Board (IRB)
The IRB is a review board that reviews research protocols involving human subjects. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence). The IRB should be diverse in its membership including diversity of race, gender, sex, age, religion, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. Each IRB shall include at least one member whose primary concerns are in scientific areas, at least one member whose primary concerns are in nonscientific areas, and at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. This is also called the IRB Full Board. (45 CFR 46.102(g) and 45 CFR 46.107(a))
Interaction includes communication or interpersonal contact between investigator and subject (45 CFR 46.102b(e)(1)(i)(3))
International Traffic in Arms Regulations (ITAR)
International Traffic in Arms Regulations (ITAR) (22 CFR § 120-130) are the set of regulations administered by the U.S. Department of State, Directorate of Defense Trade Controls (DDTC). The ITAR controls the export and import of defense articles and defense services. The ITAR contains a number of defined terms (See 22 CFR §120)
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (45 CFR 46.102b(e)(1)(i)(2))
A study involving research with human subjects has an intended change to an IRB-approved study. These intended changes must be submitted to the IRB for review and approval before those changes are implemented. Changes to a study may range from editorial to procedural. Amendment requests are reviewed at the same level the initial study was approved under. If the amendment changes the risk profile to participants or procedures that require additional levels of review, then a new review level will be implemented for the protocol.
IRB Approval means that an individual research study involving human subjects has been reviewed and approved by the IRB Full Board or IRB Office staff in accordance with the criteria for approval detailed in 45 CFR 46.111. A study that is reviewed and approved by the NC State University IRB is approved at it’s initial review as either Exempt, Expedited, or requiring Full Board Approval. Once a study is approved by the IRB it is expected that the approved protocol is adhered to. Any changes must be reviewed by the IRB before implementation through the Amendment process. Some studies require annual approval renewal.
IRB Approval Renewal (aka Continuing Review)
The review process for Full Board studies and, rarely, a few Expedited studies where the researcher renews their IRB approval once every 12 months (or more frequently as determined by the convened Full Board). 45 CFR 46.109(e) and 45 CFR 46.109(f)(1)
Material Transfer Agreement (MTA)
A contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. MTAs are also invaluable tools to ensure the recipient has clearance guidance on the regulatory requirements, including Export Control compliance, that might apply to the material. Contact the Office of Research Commercialization (ORC) if you believe your activity warrants an MTA.
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.(45 CFR 46.102j)
Non-Contextualized Controlled Research Data
Information that is raw output with no identifying marks generated, processed, stored, and/or transmitted under a controlled project subject to dissemination controls, export control regulations and federal cybersecurity rules. The information is raw output with no identifying marks for the controlled project. The information must be correlated with additional input from a person, application or second data source in scope of the controlled research project to become Contextualized Controlled Research Data thus in scope of the export control regulations and federal cybersecurity rules.
The failure (regardless of intentionality) to comply with any federal, state, or local regulation governing human research including university policies on human research. It includes any deviation from the protocol approved by the IRB, or deviations from stipulations imposed by the IRB, as a condition of approval. Noncompliance may be serious, non-serious (minor), and may be continuing. NC State University IRB Policy for Noncompliance
Not Human Subject Research
Not Human Subjects Research (NHSR) means that the research activity is not regulated by the IRB in any way because the activity is not considered human subjects research. A study would not be considered human subjects research if the answer to the questions “is it research as defined by the federal regulations?” or “is it human subjects research as defined by the federal regulations?” is no. Answering “no” to either of those questions means the IRB does not have jurisdiction to review the project and no IRB approval is necessary. Note, this determination is different from a study reviewed and determined to be Exempt.
Notice of Intent
Prior approval process required before engaging in External Activities for Pay (EPAP).
Office of Foreign Asset Controls is the office within the U.S. Department of Treasury that oversees the embargo and sanction programs.
Personally Identifiable Information (PII)
Personally Identifiable Information (PII) means information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual. Some information that is considered to be PII is available in public sources such as telephone books, public Web sites, and university listings. This type of information is considered to be Public PII and includes, for example, first and last name, address, work telephone number, email address, home telephone number, and general educational credentials. The definition of PII is not anchored to any single category of information or technology. Rather, it requires a case-by-case assessment of the specific risk that an individual can be identified. Non-PII can become PII whenever additional information is made publicly available, in any medium and from any source, that, when combined with other available information, could be used to identify an individual. (2 CFR 200.79)
Those agencies that follow the PHS Conflict of Interest Rules.
The appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. (REG 10.00.02 section 2.5)
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record) (45 CFR 46.102b(e)(1)(i)(4))
Public domain means information which is published and which is generally accessible or available to the public (22 CFR 120.34)
The shipment or transmission of an item subject to the EAR from one foreign country (i.e., a country other than the United States) to another foreign country. A reexport also occurs when there is “release” of technology or software (source code) subject to the EAR in one foreign country to a national of another foreign country.
Reliance Agreement (also called institutional authorization agreement): is a contract that allows one IRB office to rely on another IRB office for protocol review and oversight. The IRB that reviews and approves the research is called the “IRB of Record.” The IRB that does not review the research and relies on another IRB for review and approval of the project is called the “Relying IRB.” Reliance agreements are typically implemented for research with human subjects that is reviewed at the expedited or Full Board level. In rare cases, these may be completed for exemptions. NC State University does not require a reliance agreement for exemptions but will enact one if a partnering IRB requires it.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities (45 CFR 46.102(l))
Defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion. (REG 10.00.02 section 2.1)
A person against whom an allegation of Research Misconduct is made. The respondent is required to cooperate with the conduct of an Inquiry and Investigation.
For purposes of NSF, senior personnel include:
- (co) Principal Investigator (PI) — the individuals designated by the proposing/recipient organization and approved by the Federal research funding agency who contribute in a substantive, meaningful way to the scientific development or execution of a research and development project proposed to be carried out with a research and development award. NSF does not infer any distinction in scientific stature among multiple PIs, whether referred to as PI or co-PI. If more than one, the first one listed will serve as the contact PI, with whom all communications between NSF program officials and the project relating to the scientific, technical, and budgetary aspects of the project should take place. The PI and any identified co-PIs, however, will be jointly responsible for submission of the requisite project reports. For purposes of this document, when used throughout, the term Principal Investigator also includes Project Director (PD), and the term co-PI also includes co-PD.
- Faculty Associate (faculty member) (or equivalent) — an individual other than the Principal Investigator(s) considered by the performing institution to be a member of its faculty (or equivalent) or who holds an appointment as a faculty member at another institution, and who will participate in the project being supported.
Senior/Key Personnel (NIH)
The Program Director/Principal Investigator and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. NIH GPS section 1.2
Significant Financial Interest (SFI)
Salary or other payments for services such as consulting fees or honoraria; equity, interests, such as stock and stock options; and intellectual property rights, such as patents, copyrights, and royalties from such rights, that
a. In the case of salary, royalties (including those distributed to the individual through the University), or other payments, including consulting fees or honoraria, when aggregated from a single entity for the employee and his or her family, are expected to exceed $5,000 over the next twelve months; or
b. In the case of equity interest in publicly-traded entities, when aggregated for the employee and his or her family, meets either of the following tests: exceeds $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value or represents more than a (5%) ownership interest in any single entity; or
c. In the case of entities that are not publicly traded, consists of any equity interest held by the employee or his or her family.
d. When the project or proposed project requires the use of human subjects and approval from the Institutional Review Board, these minimum remuneration and equity thresholds do not apply. In such cases, the disclosure threshold is any amount of payment and any equity holding by the employee or his or her family. (REG 01.25.01)
(ITAR term) Information which is required for the design, development, production, manufacture, assembly, operation, repair, testing, maintenance or modification of defense articles. This includes information in the form of blueprints, drawings, photographs, plans, instructions or documentation (22 CFR 120.9).
(EAR term) Information necessary for the “development,” “production,” “use,” operation, installation, maintenance, repair, overhaul, or refurbishing (or other terms specified in ECCNs on the CCL that control “technology”) of an item (15 CFR part 772).
Technology Control Plan (TCP)
Project specific document used to provide clear guidelines and controls deemed necessary to safeguard controlled technical data, information or equipment that is subject to export control regulations. May also be used for federally funded research information that is subject to specific cybersecurity requirements
U.S. Government Restricted Party List
The U.S. government restricts certain exports, reexports and transfers of items to certain persons, entities and destinations. These restrictions are maintained by several federal agencies, including but not limited to the State, Treasury and Commerce Departments, on various lists. When a person or entity is on such a list, U.S. entities are expected to do additional due diligence to ensure that any proposed interaction doesn’t involve an activity that is prohibited by U.S. law. If a proposed sponsor, subcontractor or international visitor is believed to be on one of these lists, the Export Controls Team must review the situation to determine if a license is required or if the activity can be approved. The federal government maintains a free website which searches against all such list. The website is found at https://www.export.gov/csl-search. The University reserves the right to restrict additional parties based on emerging US Government legislative or administrative guidance, or when it is otherwise in the University’s best interest.
Any person who is a U.S. Citizen, lawful permanent resident (Green Card holder), or a protected individual as defined by 8 U.S.C. 1324b(a)(3); and entities that are incorporated or organized to do business in the United States. This includes U.S. subsidiaries of foreign entities.
Unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria: 1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; 2) related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and 3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized (OHRP Guidance for Unanticipated Problems)
USDA Covered Animals
All live or dead warm-blooded animals used in research except birds, rats of the genus Rattus, and mice of the genus Mus bred for research. This also excludes “cold-blooded” animals such as fish, reptiles, and amphibians.For the purposes of the Animal Welfare Regulations, teaching is equivalent to research. Using farm animals for teaching related to food or fiber, or breeding, management or production efficiency is not regulated. Using farm animals for teaching related to basic science or biomedical research is regulated.
A person who makes an allegation of scientific misconduct. (REG 10.00.02 section 2.9)